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Active Reference (Fluoxetine) Fixed-dose Study of Vortioxetine in Paediatric Participants Aged 7 to 11 Years With Major Depressive Disorder (MDD)

NCT02709655 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 683

Last updated 2022-09-22

Study results available
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Summary

Investigation of the efficacy and safety of a new potential treatment of Major depressive disorder (MDD) in paediatric participants (age 7 to 11 years).

Conditions

  • Depressive Disorder, Major

Interventions

DRUG

Vortioxetine 10 mg/day

10 mg/day, encapsulated tablet, orally (with addition of lower initial dose levels). Based on tolerability the dose may be reduced by 5 mg/day. No dose increase will be allowed

DRUG

Vortioxetine 20 mg/day

20 mg/day, encapsulated tablet, orally (with addition of lower initial dose levels). Based on tolerability the dose may be reduced by 5 mg/day. No dose increase will be allowed

DRUG

Fluoxetine 20mg/day

20 mg/day, encapsulated tablet, orally (with addition of lower initial dose levels). Based on tolerability the dose may be reduced by 10 mg/day. No dose increase will be allowed

OTHER

Placebo

Encapsulated tablet, orally

Sponsors & Collaborators

  • Takeda

    collaborator INDUSTRY

  • H. Lundbeck A/S

    lead INDUSTRY

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-18
Primary Completion
2022-01-21
Completion
2022-01-21
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Canada
  • Colombia
  • Estonia
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Latvia
  • Mexico
  • Poland
  • Russia
  • Serbia
  • South Africa
  • South Korea
  • Spain
  • Ukraine

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02709655 on ClinicalTrials.gov